Class II — Beckman Coulter Inc.
| Recalling firm | BECKMAN COULTER, INC. |
|---|---|
| Registered facility | View this company's 22 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Beckman Coulter has received a customer complaint that suggests trending of positive results has increased from approximately 4% to 1 0%. As a result of our investigation, Beckman Coulter has confirmed an increase in sensitivity at the borderline positive level. " This testing also demonstrated that the issue does not affect results reported as negative. |
| Product | Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples. |
| Quantity | 68,116 units |
| Distribution | Worldwide Distribution - USA and the country of Canada. |
| Initiated | 2013-07-17 |
| Classified | 2013-08-22 |
| Terminated | 2014-10-24 |
| Recall number | Z-1997-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Beckman Coulter Inc. (Z-1997-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65832/
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